Prospective Study Collecting Blood Samples From Kidney Transplant Patients to Detect Donor DNA

What this Trial Is About

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA dd-cfDNA to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organs status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA gDNA samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population